Legacy studies employing a single treatment course of two infusions seven days apart demonstrated greatest benefit in three early studies
Data support further investigation of novel genetically modified cell therapy in Crohn’s disease
“We pioneered the development of our placental-derived allogenic therapy because we believe that our technology has broad application across a number of therapeutic areas with high unmet need,” said
“These encouraging data showed clinically meaningful and durable response rates. For example, in a Phase 1 study, a clinical disease remission rate of 50 percent at two years as measured by the Crohn’s Disease Activity Index was observed following a single treatment course. Additionally, the clinical response rate at two years was 83 percent (5 of 6 patients). The therapy was generally well-tolerated with no dose-limiting toxicities observed,” said
“The immune pathways involved in inflammation and fistula formation associated with Crohn’s disease are now well-characterized and we believe the broad activity of APPL-001 may allow us to target some of the key drivers of these processes. Despite therapeutic advances, Crohn’s disease remains an area of significant morbidity and requires therapies to target both the inflammatory processes and fistula formation. Crohn’s disease is representative of a number of autoimmune inflammatory diseases,” said
About the Legacy Studies
This press release references the following studies:
- Safety and Tolerability of Human Placenta-Derived Cells in Treatment-resistant Crohn’s Disease: A Phase 1 Study. Mayer, et al.
Inflammatory Bowel Disease Journal . Volume 19, Number 4, March-April 2013 . - Human Placenta-derived Cells for the Treatment of Moderate-to-severe Crohn’s Disease: A Phase 1b/2a Study. Melmed,
G. Inflammatory Bowel Disease Journal . Volume 21, Number 8,August 2015 .
In addition to these studies, the Company plans to submit the abstract, “Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intra Venous Infusion of Human Placenta-Derived Cells for the Treatment of Crohn's Disease,” for presentation at an upcoming scientific meeting.
About Crohn’s Disease
Crohn's disease is a type of inflammatory bowel disease (IBD). It causes swelling of the tissues (inflammation) in the digestive tract, which can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. Inflammation caused by Crohn's disease can involve different areas of the digestive tract in different people, most commonly the small intestine. This inflammation often spreads into the deeper layers of the bowel.
Crohn's disease can be both painful and debilitating, and sometimes may lead to life-threatening complications. There's no known cure for Crohn's disease, but therapies can greatly reduce its signs and symptoms and even bring about long-term remission and healing of inflammation. With treatment, many people with Crohn's disease are able to function well. (
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Celularity Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995, as well as within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intends,” “may,” “might,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “strive,” “target,” “will,” “would” and the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. The forward-looking statements in this press release include express and implied statements regarding progressing APPL-001 into clinical studies and its potential for Crohn’s disease and the benefits of Celularity’s approach to cellular medicine, among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: the inherent risks in biotechnological development, including with respect to the development of novel cellular therapies, and the clinical trial and regulatory approval process; and risks associated with Celularity’s current liquidity, as well as developments relating to Celularity’s competitors and industry, along with those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K filed with the
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Celularity Investor Contact:
carlos.ramirez@celularity.com
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